Your safety,Our top priority

Debiopharm's vision of healthcare is not limited to making new medicines available. We strongly believe that you can be an actor in your own medical care.

The researcher

A researcher is a person who carries out scientific research. His/her job is to study a subject carefully, especially to discover new information or understand a subject better. New medicines are found in laboratories where researchers study thousands of molecules for their potential as future therapies.

The investigator

In a clinical trial, the investigator is the medical doctor responsible for the running of the trial at the trial site. He/she must ensure that the trial is conducted according to the study protocol and applicable regulations, and that the safety, welfare, and rights of the participants under his/her care are protected. The study protocol is the document that describes in detail why the trial is being done, how to do it and what to do in any eventuality. The protocol is like a user manual for a clinical trial.

informed consent form

Healthy volunteers or patients may not take part in a clinical trial unless they have voluntarily confirmed their willingness to do so after having been informed by the investigator of all aspects of the trial that are relevant to their decision to participate. This process is called informed consent and is documented by an informed consent form (I.C.F.) that is signed and dated by the participant and the investigator.

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From the lab to the patients

years of research

The researchers’ goal is to understand how the drug works and minimize the potential side effects before testing the drug in clinical trials.

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clinical trial protocol

The protocol describes the clinical trial process, including information to help your doctor advise you if you might participate, and is regulated by the health authorities.

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Patient safety

All clinical trials are regulated to ensure that your safety, well-being and rights are protected.

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Screening

Individuals who have agreed to take part in a clinical trial must go through a “screening process” before they can enter the study. The screening process consists of a set of medical questions and tests that help the investigator determine if an individual has the right medical profile for the study or not, and is based on the patient selection criteria described in the study protocol.

Type and duration

Treatment duration and type of treatment vary from one study to another and one medical field to another. In oncology studies, for example a chemotherapy treatment can last a number of 21- or 28-day cycles with the treatment administered orally or by infusion; in pediatric endocrinology a treatment might last for one year but only include two injections whose effect last 6 months; in an antibiotic study for example, patients could be treated up to 10 days with an intravenous administration followed by tablets taken orally.

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Getting involved

screening

Extensive medical examinations confirm whether you can participate in the clinical trial.

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Treatment

As a participant, you receive the treatment and are closely followed according to the protocol.

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Follow-Up

There is continuous monitoring during and after the trial to measure effectiveness and ensure there are no long-term side-effects.

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Things to consider

Benefits & risks

Carefully consider the pros and cons of joining the trial by discussing it with your doctor.

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Personal Implication

Make sure that you are aware of the time and organization that participating in a clinical trial requires.

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Understanding the treatment

Your medical team should answer all your questions: you have the right to know the kind of tests and treatment you are signing up for.

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233Clinical trials

129Countries

5Products available

1.2 MPatients treated each year

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Key facts

Participating in clinical trials truly helps develop new treatments. In fact this step is essential to define the right dosage, the effectiveness and the side effects related to any new drug.